Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326489
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-17
Brief Title:
Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus
Sponsor:
ELIAS Emergency University Hospital
Organization:
ELIAS Emergency University Hospital
Study Overview
Official Title:
Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania Primary Outcome Variations in HbA1c between baseline visit V1 - 740G and assessment visit following three months of 780G insulin pump therapy V2 - 780G
Secondary Outcomes changes in insulin requirements time in range TIR levels time below range TBR coefficient of variation CV frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization and PedsQL SF15 questionnaire scores
Secondary Outcomes changes in insulin requirements time in range TIR levels time below range TBR coefficient of variation CV frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization and PedsQL SF15 questionnaire scores
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ERP-2023-13520 | OTHER_GRANT | Medtronic | None |